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目的探讨膀胱过度活动症(OAB)治疗中安慰剂效应的影响因素。方法分析一项已完成的旨在评价OAB药物疗效的三期平行随机双盲安慰剂对照多中心临床试验的安慰剂组。将OAB治疗应答作为因变量,自变量包括人口学、OAB危险因素及OAB疾病的数据。先进行单因素Logistic回归筛选出有统计学意义的可疑影响因素,再用多因素logistic逐步回归进行分析。结果单因素Logistic回归分析结果表明,是否摄入咖啡因、病程、OAB总体严重程度、尿急严重程度、既往是否接受过OAB治疗、是否发生不良事件6个因素在统计学上差异具有显著性(P<0.1)。多因素Logistic逐步回归分析进一步显示,轻中度OAB患者更易发生安慰剂效应,而不摄入咖啡因相对于摄入咖啡因的患者更易出现安慰剂效应,其比值比(95%可信区间)分别为3.094(1.348~7.099)、3.047(1.623~5.719)。结论OAB总体严重程度和是否摄入咖啡因是治疗OAB发生安慰剂效应的独立影响因素。
Objective To investigate the influencing factors of placebo effect in overactive bladder (OAB). Methods We analyzed a completed placebo group of three parallel, randomized, double-blind, placebo-controlled, multicenter, clinical trials designed to evaluate the efficacy of OAB. OAB treatment response was taken as the dependent variable, and the independent variables included demographic data, OAB risk factors and OAB disease data. First, single-factor Logistic regression was screened out statistically significant suspicious factors, and then multivariate logistic regression analysis. Results The results of univariate logistic regression analysis showed that there were significant differences in six factors (caffeine intake, duration, overall severity of OAB, severity of urinary urgency, previous OAB treatment, and whether there were any adverse events) P <0.1). Multivariate Logistic stepwise regression analysis further showed that placebo effects were more likely to occur in patients with mild-to-moderate OAB, whereas placebo-free effects were more likely with caffeine-free versus caffeine-in-patients with a odds ratio (95% confidence interval) 3.094 (1.348 ~ 7.099) and 3.047 (1.623 ~ 5.719) respectively. Conclusions The overall severity of OAB and caffeine intake are independent predictors of placebo response to OAB.